Study Of The Safety Of CE 224,545 And Methotrexate In Patients With Rheumatoid Arthritis

This study has been completed.

First Received: March 9, 2007 Last Updated: October 12, 2007 History of Changes

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00446784

Purpose

CE 224,535 is being developed for the treatment of rheumatoid arthritis. The purpose of this study is to evaluate the safety and tolerability of CE 224,535 after 4 weeks of treatment in subjects with rheumatoid arthritis already receiving methotrexate

Condition	Intervention	Phase
Arthritis, Rheumatoid	Drug: CE-224,535 Drug: Methotrexate	Phase I

MedlinePlus related topics: Rheumatoid Arthritis

Drug Information available for: Methotrexate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety Study
Official Title:	A Phase 1, Double Blind Study Of The Safety And Pharmacokinetics Of Multiple Doses Of CE 224,535 In Subjects With Rheumatoid Arthritis Receiving Methotrexate

Further study details as provided by Pfizer:

Primary Outcome Measures:

Incidence and severity of adverse events throughout the study

Secondary Outcome Measures:

Pharmacokinetics of CE 224,535 on Days 7 and 8
Pharmacokinetics of Methotrexate on Days 1 and 8

Estimated Enrollment:	20
Study Start Date:	April 2007

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Adults patients with rheumatoid arthritis
Patients who have received stable weekly doses of oral methotrexate (5 to 25 mg/week administered as a single dose) for a minimum of 28 days (4 weeks/4 doses)

Exclusion Criteria:

History of chronic infectious disease such as genitourinary, pulmonary or sinus infections.
Any current or known malignancy or history of malignancy within the previous 5 years
Pregnant or lactating women; women of child-bearing potential who are unwilling to unable to use an acceptable method of birth control during the study

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00446784

Locations

United States, Florida
Pfizer Investigational Site
Ocala, Florida, United States, 34471
Pfizer Investigational Site
Ocala, Florida, United States, 34474
Pfizer Investigational Site
Miami, Florida, United States, 33169
United States, Michigan
Pfizer Investigational Site
Kalamazoo, Michigan, United States, 49007
United States, Pennsylvania
Pfizer Investigational Site
Ducansville, Pennsylvania, United States, 16635

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	A6341006
Study First Received:	March 9, 2007
Last Updated:	October 12, 2007
ClinicalTrials.gov Identifier:	NCT00446784 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Antimetabolites
Autoimmune Diseases
Immunologic Factors
Joint Diseases
Arthritis, Rheumatoid
Rheumatic Diseases
Folic Acid Antagonists

Immunosuppressive Agents
Folic Acid
Musculoskeletal Diseases
Arthritis
Connective Tissue Diseases
Methotrexate
Antirheumatic Agents

Additional relevant MeSH terms:

Antimetabolites
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Arthritis, Rheumatoid
Reproductive Control Agents
Musculoskeletal Diseases
Arthritis
Therapeutic Uses
Abortifacient Agents
Connective Tissue Diseases

Methotrexate
Dermatologic Agents
Nucleic Acid Synthesis Inhibitors
Autoimmune Diseases
Immune System Diseases
Joint Diseases
Enzyme Inhibitors
Rheumatic Diseases
Abortifacient Agents, Nonsteroidal
Folic Acid Antagonists
Immunosuppressive Agents
Pharmacologic Actions
Antirheumatic Agents

ClinicalTrials.gov processed this record on May 07, 2009